Technician, GMP Production

CSBio Co.; Milpitas (CA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

401k match

PTO 10 days

Paid holidays

Life insurance

Disability insurance

Carpool reimbursement

Team events

Job summary

CSBio is seeking a GMP Production Technician at its Menlo Park and Milpitas facilities. The role focuses on the synthesis, cleavage, purification, and freeze-drying of peptides in our GMP manufacturing areas, under supervision and in a fast-paced environment.

Responsibilities include following batch records, operating HPLCs, mass spectrometers, and other lab equipment; documenting data; maintaining cleanliness; and contributing to product quality.

Qualifications

• Experience with peptide synthesis and/or purification processes.
• Ability to follow batch production records and SOPs.
• Excellent communication and teamwork skills.

Responsibilities

• Perform synthesis and cleavage of peptides per batch records.
• Operate HPLCs, centrifuges, freeze dryers and mass spectrometers.
• Record data and ensure accuracy and cleanliness of the lab.
• Maintain safety and quality in GMP environment.

Skills

Synthesis

Purification

Data analysis

Teamwork

Tools

HPLC

Mass spectrometry

Freeze dryers

Centrifuges

Laboratory balance

Job description

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

We are seeking qualified individuals to join us as GMP Production Technican at our Menlo Park and Milpitas facility. This position will be responsible for the synthesis/cleavage of peptides OR the purification/freeze drying of peptides in our GMP manufacturing areas. Core duties and responsibilities include the following:

GMP Synthesis

• Execute batch production records or protocols for synthesis and cleavage processes with minimal supervision in a timely and efficient manner
• Analyze organic and inorganic compounds to determine chemical and physical properties
• Conduct research on manufactured products to develop and improve product quality
• Perform data analysis and review of data for accuracy and completeness

GMP Purification

• Identify the fully protected 20 amino acids batch by batch in terms of solubility and appearance
• Operate laboratory equipment and instruments including: HPLCs, centrifuges, freeze dryers, stir plates, lab balance, mass spectrometers, sonicators, vacuum ovens, N2 tanks, etc.
• Record purification and other experiments on standardized forms
• Check analytical HPLC and mass of dissolved crude peptides properly
• Identify target peptide peak by integration and mass spectrometry

Both

• Read work orders thoroughly and have a good understanding of instruction and specification of final products.
• Prepare and label chemical solutions according to standard formulas.
• Maintain a clean working environment and contribute to overall lab cleanliness.
  

• Able to work on Saturdays and/or Sundays
• Excellent communication skills
• Ability to work independently and as part of a team
• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities